Sr. Associate, Development Sciences Business Operations

Location:  San Rafael, California Category: Clinical

Description

OVERVIEW:

The Development Sciences Business Operations (Business Operations) group is the center of excellence for providing industry best practice operational support for the conduct of BioMarin’s global clinical trials, including strategic vendor oversight, clinical financial spend analysis and management, vendor contract management and clinical site budgets.  The group utilizes rigorous processes, procedures, and tools to ensure financial discipline and transparency in vendor and site spend, assists with financial and resource projections across clinical projects and studies, manages the development, negotiation and execution of clinical site budgets and vendor contracts, as well as facilitates effective clinical vendor oversight.

Key responsibilities of Business Operations include: aligning with Clinical Operations and Clinical Sciences on understanding clinical trial strategy in order to successfully contribute to trial execution; portfolio- and/or program-level vendor selection and contracting strategy, including negotiation of scope and budget for proposed vendor services in line with clinical trial assumptions, drivers and milestones; quantitative analysis of vendor bids and proposals; drafting and negotiating vendor contract documents; liaising with study execution teams regarding all aspects of contract strategy and management; contributing to vendor performance oversight; and developing and managing clinical trial forecasts and budgets in partnership with key stakeholders

 

SUMMARY DESCRIPTION:

The Senior Associate, Business Operations, holds a key support position within Business Operations.  Under the leadership of the Business Operations Program Lead, the compound-focused Business Operations teams are responsible for the following deliverables for their clinical development program: contracts management and certain negotiation; vendor oversight; clinical site budgets and contracts; and financial oversight. 

The Senior Associate, Business Operations, will contribute to the overall clinical portfolio business operational activities across Business Operations in collaboration with Global Strategic Sourcing and Clinical Operations to optimize clinical trial spend and empower Study Execution Teams regarding vendor-related decisions without sacrificing quality, timelines or performance.  The Senior Associate, Business Operations will participate in one or more compound-focused program teams in support of BioMarin’s clinical trial execution. 

KEY RESPONSIBILITIES:

Vendor Contracting and Oversight

  • Understand and assist in driving the vendor contracting strategy within assigned programs and provide input for the same at the portfolio level. 
  • Collaborate with Global Strategic Sourcing (GSS) around strategic outsourcing and vendor selection activities.
  • Partner with GSS and the Study Execution Teams in the review of vendor proposals, including the qualitative analysis and comparison of vendor proposals and budgets in competitive bidding.
  • Facilitate negotiation of vendor scopes of work and budgets, including communications with vendors and drafting of final contracts in collaboration with the Business Operations team member assigned to support each vendor.
  • Support vendor selection on behalf of the Study Execution Teams for any vendors not directly supported by GSS, including DSMB, Steering Committees, and Regulatory vendors.

 

Clinical Site Contracting

  • Contribute to the successful collaboration of Business Operations with key stakeholders (e.g.: Study Execution Teams, Global Project Management and GSS) to collect key assumptions required for the development of clinical trial contracts and associated budgets. 
  • As directed by the Business Operations team members supporting each clinical trial, support the drafting and negotiation of clinical site budgets and contracts, including some direct communication with sites and/or facilitate managing vendors where these activities are outsourced to a third party (e.g., contracts with sites outside of the US).
  • Partner closely with BioMarin’s Legal Department in the negotiation of certain site contracts (e.g., confidentiality agreements).

 

Financial Management

  • Partner with others on the Business Operations team in the use of the BOARD platform to improve financial management and forecasting of study costs for contract management and vendor oversight.
  • Support financial transparency and accountability in vendor and clinical trial site contracting.
  • Understand savings and/or cost increases resulting from changes in outsourcing strategy, contracting, and/or clinical trial assumptions.
  • Support the financial oversight of clinical vendors, including identifying trends and potential financial risks, as well as support review of financial information for quarterly Executive Oversight Meetings.

 

General Responsibilities

  • Ensure timely contract execution by supporting systems, processes and structures that support achievement of aggressive operational and scientific goals.
  • Partner with the Study Execution Teams, functional areas SMEs, and Business Operations colleagues to understand the impact of identified changes to trial scope, supplier scope, budgets and forecasts.  Work with Finance on any accruals and forecast updates associated with such changes.
  • Facilitate collaboration with Compliance and Development Sciences Quality to ensure coordination of vendor audits and relevant follow up activities. Facilitate proper documentation, archiving and inspection-readiness of all Business Operations managed contracts.
  • Identify opportunities for building efficiencies into the process of clinical site and vendor contracting.

 

 

KEY COMPETENCIES:

The Senior Associate, Business Operations is expected to demonstrate foundational skills across a range of Business Operations core competencies, including:

  • demonstrating commitment to business ethics and adherence to core business values;
  • ability to plan, prioritize, and organize work timelines and tasks to support timely execution;
  • using rigorous logic to identify and propose solutions to address challenges;
  • leveraging knowledge of the organization to support decision-making and resolution of complex issues;
  • driving for results in self, including a commitment to model proactivity and continuous improvement;
  • having an ability to quickly establish rapport with cross-functional team members;
  • Understanding and applying basic accounting and finance terminology, processes, and methods, and is also knowledgeable around BioMarin-specific finance and accounting processes and stakeholders
  • communicating concepts and results clearly and comfortably to Business Operations leadership.

 

The Senior Associate, Business Operations must also demonstrate foundational skills in multiple technical competency areas, including:

  • contributing to cross-functional decisions regarding financial impact of contracting;
  • understanding big picture implications and considerations of drug development strategies;
  • providing input into weighing vendor preferences due to trial/project synergies, executive preference, etc. with the preferences of a particular team to optimize BioMarin’s financial and operational performance;
  • supporting an organization-wide view on how financial and accounting decisions are made and the impact on corporate finance, reporting, and executive decision-making;
  • embracing a culture that values the importance of process, technology, and performance measurement to drive improvement;
  • demonstrating knowledge of GCP guidelines and their impact on each stage of the trial (start-up through close-out);
  • contributing to financial scenario analyses; and
  • proactively investigating and resolving contracting and budgeting issues.

 

EDUCATION AND EXPERIENCE:

  • BA/BS in finance, accounting, health sciences, or related degree. Advanced degree preferred.  Experience in lieu of education is considered.
  • 2-5 years of relevant experience (including technical experience with clinical site and/or vendor contracts and budgets) working in the pharmaceutical industry (including CROs)